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FDA has previously published a discussion paper that was produced to inform its guidance on AI in pharmaceutical drugdevelopment. Article: Adopting AI for R&D in 2025 what needs to be addressed? The post FDA issues first recommendations on AI for drugdevelopment appeared first on European Pharmaceutical Review.
billion in January 2025, according to data from GlobalData. These three transactions accounted for 64 per cent of the total M&A deal value in January 2025. per cent in January 2025 compared to the same period last year. billion in Jan 2025 appeared first on Express Pharma. A total of 129 VC deals worth $4.5
Building upon the foundation laid by previous initiatives, the Union Budget 2025 could prioritise targeted incentives for AI in research and development, which will accelerate innovation in drug discovery, clinical trials, and personalised patient care.
Large Pharma companies in India have already been appointing North America focused Regulatory Affairs leadership roles, responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with regulatory agencies, and being responsible for all associated regulatory filings.
If everything proceeds on time, drug and medical device makers will be required to submit plans for meeting diversity standards by the end of March 2025. To ensure that drugs work for everyone, they must be tested on a representative sample of people. The FDA is set to draft guidance for those plans by the end of the year.
Leading FDAs implementationof the Drug Competition Action Plan (DCAP). The DCAP was an initiative launched in 2017 to remove barriers to generic drugdevelopment, approval, and market entry (see our previous post here ). Overseeing the development, clearance, and issuance of every policy document FDA issued on generic drugs.
Join the 6th Cytokine-Based DrugDevelopment Summit organised by Hanson Wade on May 15th to 16th, 2025. Stay updated on the latest advancements in cytokine-based drugdevelopment.
As the company said it was going to spend more money on research, it also withdrew earnings outlooks for 2025. ” Sanofi unveiled its R&D plans late last month as it announced its third-quarter performance and said that it was spinning out its consumer health division.
January 30, 2025: “The U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults.
Additionally, Novo Nordisk’s novel Phase III candidate, NN-9932, which is expected to be launched by the end of 2025, has the highest probability of success among all drugs in this category, with a 35 per cent likelihood of approval (LoA).” Novo Nordisk and Eli Lilly have already reaped substantial rewards in the injectable segment.
During the course of the webinar, Keefer explained how specialty sites, with deep knowledge on one or certain groups of Rare Diseases, are crucial for further progress in drugdevelopment to progress the number of treatments available to Rare Disease patients and to provide support to those individuals.
To address growing demand from the pharmaceutical industry, Asahi Kasei has launched a new division, Asahi Kasei Life Science, effective from 1 April 2025. The new structure is designed to unify its bioprocess businesses and streamline services offered to pharmaceutical partners across drugdevelopment and manufacturing.
Join the Proteomic Based Drug Discovery Summit 2025 to stay updated on the latest trends in drugdevelopment and network with industry experts. Visit our website to register and be part of this exciting event.
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The China-based cancer drugdeveloper’s offering will fund testing of medicines for several blood malignancies — one of which is part of an alliance with Takeda.
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In brief, the European plan for Chiesi is in-house drugdevelopment of biologicals and rare disease targeting. The Parma site is due to become operational from 2024, with FDA, IFA, and EMA approvals due to be sought for 2025.
In 2025, pharmaceutical trends are redefining how brands connect with healthcare professionals (HCPs), patients, and stakeholders. With machine learning and big data analytics, companies can now predict market trends, enhance drugdevelopment, and create hyper-personalized campaigns.
Hyman, Phelps & McNamara PC, (HPM), which will mark its 45thAnniversary on March 17, 2025, is pleased to announce that it is increasing its directors, counsel, and associates as it starts the year. Richardson has been promoted to Director.
The DDiCT project will be co-led by Bristol Myers Squibb (BMS)’s Disability Advancement Workplace Network (DAWN) and the Global DrugDevelopment Team. The goal is to “ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies,” a statement said.
The deal also includes around 400 staff employed by Alkermes in drugdevelopment and manufacturing. Additionally, Alkermes and Novo Nordisk plan to agree subcontracting arrangements to continue certain work currently performed at the facility, potentially until the end of 2025. The transaction is expected to close in mid-2024.
Amgen drugdevelopment highlights – November 2023 In November 2023, Phase II trial results for immunotherapy tarlatamab demonstrated an ability to provide sustained anti-tumour activity in 40 percent of the small cell lung cancer trial patients.
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Japans Ministry of Health, Labor, and Welfare (MHLW) announced a new 10-year government fund in January 2025 to support innovative drugdevelopment. Sahu adds, Japans aging population is driving demand for innovative treatments in regenerative medicine, personalised therapies, and AI-driven drug discovery.
A recent report from GlobalData noted that AI is being used to enhance computer-aided drug design (CADD) in a bid to reduce the time and costs involved in getting new drugs to market, and predicted that pharma spending on AI drug discovery would hit $3 billion in 2025. The Pharma.AI
The American Conference Institutes 3rd Annual Forum on Advanced Therapeutics is scheduled to take place from March 19-20, 2025, at the Seaport Hotel in Boston, MA.
First, advanced research and development (R&D) and biologics will be critical. To move from generics to novel drugdevelopment, Indian companies must invest heavily in R&D for innovative therapies like biosimilars, cell and gene therapies, and specialty drugs.
Stephanie Miller, PhD discusses how artificial intelligence can revolutionize medical research by assisting in drugdevelopment and potentially providing more targeted treatments across various diseases.
Jakafi’s landmark approval in 2011 galvanised intensive drugdevelopment efforts by providing a strong positive investment signal for this market, as Jakafi is a blockbuster agent. Sam Warburton, Oncology Analyst at GlobalData, comments, “Despite MF being a rare disease, it is a blockbuster market with significant commercial potential.
Together, we aim at making the drug discovery process more efficient and effective in particular when very limited information is available to support drug design.”. It’s part of a larger trend of big pharmas hedging their bets with partnerships with AI firms to find more drug candidates faster.
The development is for expansion of the company’s in-house drugdevelopment of biologicals and rare disease targeting and the site is due to become operational from 2024, with FDA, IFA, and EMA approvals due to be sought for 2025.
EyePoint Pharmaceuticals will also receive potential royalties on the combined net sales of Iluvien and Yutiq in the US from 2025 to 2028. EYP-1901 is an investigational sustained delivery intravitreal anti-VEGF treatment which is now being evaluated in Phase II clinical trials.
Pharma companies have begun to explore a host of novel digital endpoints that could have far-reaching implications for accelerating drugdevelopment and adoption. There is a lot of investment in this area now, but we won’t start to see any significant volume of results until 2024-2025,” remarks Reites. Novel digital endpoints.
As data and digital technology become vital to every aspect of life sciences, the industry is increasingly looking beyond biologists, chemists, and doctors to drive its drugdevelopment – and finding that technology has a chief role to play in the future of medicine. According to an article by Stephens, Zachary D.,
UK-based PureTech – which develops its own therapies and also has interests in a wide range of companies including digital health players Akili and Sonde as well as drugdevelopers Vedanta, Gelesis and Follica – said it has “exchanged indicative, non-binding proposals” with Nektar that have no guarantee of leading to a deal.
Audience-favorite sessions included a discussion led by Michaeleen Crowel and Martin Riser from the S-3 Group outlining how the recent elections impact the lame duck session and health policy in early 2025. We look forward to building on these conversations at the 2025 Washington Representatives Retreat in Annapolis on November 20 – 21!
In-house drugdevelopment of biologicals and rare disease targeting. In brief, the European plan for Chiesi is in-house drugdevelopment of biologicals and rare disease targeting. Technology is to combine within its bounds, he said, so that it is possible to go from start to finish in drugdevelopment.
Arora explains that pharma associations like the Indian Pharmaceutical Association (IPA) organise training and development programmes through sessions, workshops, and webinars focused on the latest trends and technologies in R&D.
There is also a high unmet need in the CNS space, and there have been a number positive results with respect to drugdevelopment; as a result, we expect this to be a therapeutic area with dealmaking potential,” Baral continues. We expect the growth gap to increase to $120 billion across the top 25 biopharma companies by 2028.
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